cosmetic medicine

Four separate studies[i] representing the findings of clinical trials in the U.S., Canada and Europe have confirmed the value of onabotulinumtoxinA in treating and preventing chronic migraine in adults. These studies found that treatment with botulinum toxin type A was associated with significantly fewer headache days, less headacherelated disability, and significantly improved quality of life.

Results of the studies are being presented this week at the 14th International Headache Congress hosted in Philadelphia by the American Headache Society (AHS).

“This is an important advance in migraine prevention ,” said David Dodick, M.D., lead author of the study. “Patients afflicted with chronic migraine are severely disabled. Very few preventive treatments have been investigated for chronic migraine, and none is yet approved.” Of the 36 million Americans estimated to have migraine, about 6 million suffer from chronic migraine; most are undiagnosed and inadequately treated.

One of the four studies (Dodick et al.)[ii], a phase III doubleblind, parallelgroup, placebocontrolled multicenter phase 3 study involving 705 adults with chronic migraine at 66 sites, found that prophylactic treatment with onabotulinumtoxinA resulted in statistically and clinically meaningful improvements for all endpoints.

“Subjects were randomized to receive onabotulinumtoxinA or placebo injections every 12 weeks to determine changes in the number of headache days at the end of 24 weeks,” Dr. Dodick said. “We found that the group on onabotulinumtoxinA not only experienced fewer headache days, but also showed significant reduction in migraine episodes, total hours of headache per month, and headacherelated disability. This resulted in improved functioning and quality of life.

A second study by Lipton et al.[iii] comparing quality of life measurements for subjects on onabotulinumtoxinA vs. placebo found the magnitude of the improvement in headacherelated quality of life to be “highly statistically significant and reflects clinically meaningful improvements in functioning and vitality, and a decrease in psychological distress.” “Migraine is an extremely debilitating medical condition for many sufferers,” said Richard B. Lipton, MD, lead author of the study and Director of the Montefiore Headache Center in New York City. “The relief that onabotulinumtoxinA brings and the enormous improvement in functioning and vitality is striking.”

More than 400 scientific papers and posters are to be presented during the IHC/AHS meeting which is expected to draw some 1,200 migraine specialists and scientists from around the globe. The meeting is the worlds largest professional conference on migraine and headacherelated diseases.

[i] “Botulinum neurotoxin type A for treatment of chronic migraine PREEMPT 1 trial doubleblind phase”
Aurora SK et al
“Botulinum neurotoxin type A for treatment of chronic migraine PREEMPT 2 trial doubleblind phase”
Dodick DW et al
“Botulinum neurotoxin type A for treatment of chronic migraine analysis of the PREEMPT chronic migrainesubgroup with baseline acute headache medication overuse,” Silberstein SD et al.
“Botulinum neurotoxin type A treatment improves healthrelated quality of life and reduces the impact ofchronic migraine results from the doubleblind phase of the PREEMPT clinical program,” Lipton RB et al.

[ii] “Botulinum neurotoxin type A for treatment of chronic migraine PREEMPT 2 trial doubleblind phase”Dodick DW1, Smith TR2, Becker WJ3, Gendolla A4, Relja M5, Martin V6, Reyes C7, Lei X7 and Turkel CC71Neurology, Mayo Clinic Arizona, Phoenix, AZ, USA; 2Ryan Headache Center, St. Louis, MO, USA; 3Clinical Neurosciences, University of Calgary, Calgary, AB, Canada; 4Kliniken Ruhrhalbinsel, Essen, Germany; 5Neurology, Medical School University of Zagreb, Croatia; 6Internal Medicine, University of Cincinnati, Cincinnati, OH, USA; 7Allergan, Inc., Irvine, CA, USA

[iii] “Botulinum neurotoxin type A treatment improves healthrelated quality of life and reduces the impact of chronic migraine results from the doubleblind phase of the PREEMPT clinical program”
Lipton RB1, Varon S2, Grosberg B3, McAllister PJ4, Freitag F5, DeGryse RE2 and Turkel CC2 1Neurology, Albert Einstein College of Medicine, Bronx, NY, USA; 2Allergan, Inc., Irvine, CA, USA; 3Neurology, Montefiore Headache Center, Bronx, NY, USA; 4Associated Neurologists of Southern Connecticut, Fairfield, CT, USA; 5Diamond Headache Clinic, Chicago, IL, USA

Medtronic (NYSE MDT) today recognized Henning Dralle, M.D., Professor at the University of HalleWittenberg in Halle, Germany, who received the World Journal of Surgery award for Best Paper of 2008. Professor Dralle received the award as lead author for the paper, “Intraoperative Monitoring of the Recurrent Laryngeal Nerve in Thyroid Surgery,” published in the Feb. 2008 issue of WJS, on Sunday, Sept. 6 at the annual International Surgical Week conference in Adelaide, Australia. Professor Dralle accepted this award on behalf of the papers co authors and the German IONM (Intraoperative Nerve Monitoring) Study Group.

“We commend Professor Dralle for his excellent work in identifying riskminimizing tools to avoid recurrent laryngeal nerve palsy,” said Carla Pagotto, Product Manager for Intraoperative Nerve Monitoring with Medtronic ENT, part of the Surgical Technologies business at Medtronic. “Tools like Medtronics own intraoperative nerve integrity monitors are designed to combine both hardware electronics and software to help surgeons perform critical procedures while preserving nerve function and improving patient safety.”

In the awardwinning paper, Professor Dralle concludes, “Apart from navigating the surgeon through challenging anatomies, intraoperative nerve monitoring may lend itself as a routine adjunct to the gold standard of visual nerve identification.”

Motor nerves perform critical functions in the human body. Specifically, cranial nerves from the brain perform critical functions in the head, face, and neck. At times, these nerves are hard to identify during surgery due to disease, a previous operation, or normal anatomical variations. Patients can suffer temporary or permanent damage if a nerve is irritated or injured.

As Professor Dralles paper discusses, the recurrent laryngeal nerve, a branch of the vagus nerve, is one of the nerves at risk during thyroid surgery and other neck dissections. Damaging this nerve can severely impact an individuals ability to speak and swallow. Intraoperative nerve monitoring can help surgeons reduce the risk of nerve damage during surgery, giving patients and surgeons greater peaceofmind.

Published monthly, the World Journal of Surgery reaches an international audience and communicates important advances in surgical techniques and research to professionals and students in the field of surgery.

About the Surgical Technologies Business at Medtronic

Medtronics Surgical Technologies business develops products for the diagnosis and treatment of chronic diseases and disorders of the ear, nose and throat; surgical devices and implantable products for the treatment of cranial, spinal and specialty smallbone conditions; and stateoftheart navigation equipment used in operating rooms to assist physicians in neuro and spinal surgery procedures.

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American Institute for Plastic Surgery, one of the leading plastic surgery centers in the metroDallas area, is using Artefill to help patients fight wrinkles for good.

Artefill is the first and only FDAapproved microsphereenhanced collagen filler for the correction of smile lines and is one of the cutting edge products cofounders Dr. Peter Raphael and Dr. Scott Harris have been using to treat patients who want a dermal filler that lasts more than a few months.

Dr. Raphael commented, “As surgeons, we are drawn to products that offer longterm solutions and Artefill fills this need for our patients that want a lasting solution for wrinkle correction. We find Artefill offers enormous value as it lasts longer than any other filler on the market today.”

Artefill is a simple, inoffice procedure that takes approximately fifteen minutes to complete. A patient is injected with the product similar to other dermal fillers with the key difference being its lasting effect. The unique microspheres in Artefill are not absorbed by the body and therefore provide the support the skin needs for long lasting natural feeling results. This is different from temporary dermal fillers that are made of different kinds of natural or synthetic materials that are completely absorbed by the body over time and require repeat injections to maintain wrinkle correction. A skin test is required prior to treatment or approximately four (4) weeks ahead of time, to ensure a patient is not allergic to the collagen or anesthetic in Artefill.

One of Dr. Raphaels patients said, “I have tried the other fillers but I never felt fully satisfied. It was also tiring coming back into the office every few months for a touch up. Since having Artefill, I look and feel younger. It was worth paying a little extra money upfront for a product that will actually last.”

Artefill is only offered by a select group of physicians in Texas and is not available at all physician offices. Drs. Raphael and Harris are a few of the company trained and select few company sponsored physicians who have the skills and experience needed to administer the product.

About Artefill

Artefill is the first and only FDAapproved microsphereenhanced collagen filler for the correction of nasolabial folds, better known as smile lines. The safety and effectiveness of Artefill has been extensively studied over the past eight years. Since Artefill was approved in 2006, over 10 thousand patients have been treated successfully with very high satisfaction rates.

Suneva Medical, Inc., a medical technology company focused on developing, manufacturing and commercializing novel, differentiated aesthetic products for the dermatology, plastic and cosmetic surgery markets, markets and manufactures Artefill.

About American Institute for Plastic Surgery

Dr. Peter Raphael and Dr. Scott Harris are boardcertified by the American Board of Plastic Surgery and members of the American Society of Plastic Surgeons. They cofounded The American Institute for Plastic Surgery, a 15,000 squarefoot worldclass facility that provides plastic surgery services to thousands of patients from around the world.

Candela Corporation (NASDAQ CLZR) announced that two studies have reported superior results on patients who benefited from the Candela Vbeam® laser treatments for bruising resulting from cosmetic procedures. The studies concluded that the Vbeam pulseddye laser significantly expedited the healing process, improved outcomes, and provided greater overall patient satisfaction.

A study published in the March/April 2009 edition of the Archives of Facial Plastic Surgery, entitled “PulsedDye Laser for Treating Ecchymoses After Facial Cosmetic Procedures” by DeFatta, R. J., Krishna, S., and Williams, E. F., III concluded that “the Vbeam laser treatment resulted in a 63% mean improvement in ecchymoses scores within fortyeight (48) to seventytwo (72) hours.”

The second study, a 2009 ASLMS abstract, entitled “A Simple Solution to a Common Problem” evaluated the effectiveness and safety of the longpulse PDL (the Vbeam) for the treatment of ecchymoses. In this study by Elizabeth Hale, M.D., Julie Karen, M.D., Chris Hunzeker, M.D., Elliot Weiss, M.D., Leonard Bernstein, M.D., Lori Brightman, M.D., Anne Chapas, M.D., and Roy Geronemus, M.D. results showed that twentyfour hours posttreatment with the Vbeam laser, the average improvement was 62% and 13% for treated and untreated bruises, respectively.

Edwin F. Williams, M.D., Director, The Williams Center Plastic Surgery Specialists, and nationally recognized plastic surgeon pioneered this breakthrough Vbeam treatment. “Anytime you penetrate the skin there is a potential for bruising and we find that it is the bruising which occurs after many of these procedures that prevents patients from getting out into the public. It is extremely difficult to cover these unsightly marks with makeup and bruising can last for a number of weeks,” said Dr. Williams. Dr. Williams continued, “After just one treatment with the Vbeam, our patients experience dramatic clearance of the injured blood vessels. This treatment is a significant differentiator to our practice and we are excited to finally be able to offer our patients a safe and easy treatment of bruising that works!”

Roy G. Geronemus, M.D., Director, Laser & Skin Surgery Center of New York, commented, “There are millions of surgical and injectable procedures performed every year which often have bruising as a side effect that can last up to two weeks.” Dr. Geronemus continued, “This is a significant new use for the Vbeam which was already our “workhorse” laser because of its efficacy and safety profile for a wide variety of applications including skin rejuvenation, the treatment of rosacea, acne, diffuse redness, scars and more.”

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